Live: One Dial-in One Attendee
Corporate Live: Any number of participants
Recorded: Access recorded version, only for one participant unlimited viewing for 6 months ( Access information will be emailed 24 hours after the completion of live webinar)
Corporate Recorded: Access recorded version, Any number of participants unlimited viewing for 6 months ( Access information will be emailed 24 hours after the completion of live webinar)
Clinical trials are expensive, time-consuming, and labor-intensive. And in the traditional sense, study designs are inflexible.
Adaptive study designs allow for flexibility during a clinical trial. Options can be built into a study to use data collected that has accumulated at interim time points to:
The U.S. Food and Drug Administration (FDA) and other regulatory agencies require the minimization of bias in study design and analysis. In order to minimize bias, particular steps and safeguards, using regulatory guidance and sound statistical principles, must be put into place to assure validity of an clinical.
Therefore a number of considerations must be made in the design of an adaptive trial to enhance flexibility while minimizing bias, and ensuring statistically valid and well-informed decisions. Problems can arise in an adaptive design due to selection bias, interim analysis “look-sies”, and when merging dose selection and confirmation phases into one trial.
The benefits of a clinical trial with an adaptive design include savings in both time and dollars, to the desired end of bringing useful drug treatments and devices to patients more quickly.
The role of statistics in clinical trials incorporates the tools used to develop a robust study, minimize bias, and assess efficacy of new treatments as relates to comparison to competing therapies. The objective of the seminar is to provide information that can be used immediately by personnel involved in the design and analysis of clinical trials. The presentation involves use of statistical techniques and a basic understanding of statistical theory and the framework of randomized controlled trials is desired. However, presentation of statistical theory and application will be limited to only what is needed by the attendees to understand and implement adaptive trial design and analysis.